510(k) · Cleared
ClearedEsophageal Mapping Catheter, Model D-1272-01-S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosense Webster, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Aug 14, 2006 as substantially equivalent to K954390 (Cordis Webster, Inc., 1995) and 1 other predicate after an 80-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Aug 14, 2006
- Review
- 80 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K833621 (1983). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK833621 Entri Flex Feeding TubeBiosearch Medical Products, Inc. · 1983
- This deviceK061463 Esophageal Mapping Catheter, Model D-1272-01-SBiosense Webster, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K833621 | Entri Flex Feeding Tube | Biosearch Medical Products, Inc. | 1983 | — |
| 0 (this device) | K061463 | Esophageal Mapping Catheter, Model D-1272-01-S | Biosense Webster, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DRF device
- #1 K252794 Vision-MR™ Diagnostic Catheterscore 13.7 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K954390 | Cordis Wester Star CatheterSummary page 1…Electrode Recording Catheter (per 21 CFR 870.1220, Product Code DRF) Predicate Devices: a) Star Diagnostic Catheter (K954390) (later renamed NaviStar Diagnostic Catheter) b) ENTRIFL… | 1995 |
| * | K833621 | Entri Flex Feeding TubeSummary page 1…ostic Catheter (K954390) (later renamed NaviStar Diagnostic Catheter) b) ENTRIFLEX Feeding Tube (K833621) Manufacturer: Biosense Webster, Inc. 3333 Diamond Canyon Rd.… | 1983 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K954390.
How does its category compare?
All DRF devicesDRF Catheter, Electrode Recording, Or Probe, Electrode Recording: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRF
45in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRF
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRF
508in 2025
MAUDE reports naming product code DRF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 2 | 120 |
| 2008 | 2 | — | 4 | 176 |
| 2009 | 7 | 243 | 0 | 122 |
| 2010 | 5 | 65 | 0 | 130 |
| 2011 | 3 | 190 | 6 | 245 |
| 2012 | 1 | — | 0 | 402 |
| 2013 | 2 | — | 0 | 310 |
| 2014 | 1 | — | 2 | 349 |
| 2015 | 3 | 29 | 1 | 327 |
| 2016 | 8 | 175 | 0 | 383 |
| 2017 | 7 | — | 0 | 458 |
| 2018 | 1 | — | 0 | 723 |
| 2019 | 10 | 163 | 0 | 669 |
| 2020 | 4 | — | 0 | 651 |
| 2021 | 12 | 124 | 0 | 625 |
| 2022 | 8 | 283 | 0 | 613 |
| 2023 | 5 | 45 | 0 | 685 |
| 2024 | 4 | — | 0 | 623 |
| 2025 | 3 | — | 0 | 508 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Biosense Webster ESOPHASTAR™ Esophageal Mapping Catheter and related accessory devices are indicated for catheter-based anatomic mapping of the esophagus. When used during an electrophysiology ablation procedure, the EsophaStar is intended to be used in addition to other tools and techniques used to assist the physician in obtaining generalized location information of the esophagus with respect to the heart. The device is not intended to provide absolute esophageal wall location information. The Biosense Webster ESOPHASTAR™ Esophageal Mapping Catheter is placed in the esophagus via the transpharyngeal or transnasal approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061463 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061463: Esophageal Mapping Catheter, Model D-1272-01-S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061463
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026